AVEO Oncology Announces Presentation of AV-380 Preclinical Data in Cancer Associated Cachexia at 2015 Annual Meeting of the American Association of Cancer Research

Press Release

AVEO Oncology Announces Presentation of AV-380 Preclinical Data in Cancer Associated Cachexia at 2015 Annual Meeting of the American Association of Cancer Research

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 20, 2015--
AVEO Oncology (NASDAQ:AVEO) today announced the presentation of results
from a preclinical study of AV-380, the Company’s potent, humanized
inhibitory antibody targeting growth differentiation factor 15 (GDF15),
in a cachectic human tumor xenograft model with significantly increased
plasma GDF15 levels. The data were presented in a poster titled
“Effective treatment of cancer associated cachexia by AV-380, a GDF15
inhibitory antibody” at the 2015 Annual Meeting of the American
Association of Cancer Research in Philadelphia from April 18-22.

One of the most lethal and debilitating effects of cancer is the
development of cachexia. It affects the majority of advanced cancer
patients and is thought to be responsible for approximately 30% of all
cancer deaths. Cachexia is a complex metabolic syndrome associated with
malnutrition and severe involuntary weight loss due to the loss of
muscle and fat tissue, as well as the clinical manifestation of anemia,
inflammation and suppression of immune functions. Current evidence
suggests that a pro-inflammatory state may be responsible for many of
the symptoms associated with cachexia. GDF15 is a pro-inflammatory
cytokine whose elevated circulating levels are significantly correlated
with cachexia in cachectic cancer patients and several animal models of
cancer cachexia.

For the study, mice bearing HT-1080 were treated either with AV-380, or
a control antibody. The effect on body weight, muscle/fat mass and organ
sizes were assessed. Metabolic changes induced by the treatment were
measured by a comprehensive laboratory animal monitoring system (CLAMS).
Results demonstrated that the inhibition of GDF15 function results in
the complete reversion of the phenotypic and metabolic changes
associated with cancer-related anorexia-cachexia syndrome, or CACS,
completely reverting body weight loss and restoring normal body
composition of the tumor bearing mice. AV-380 treatment resulted in a
catabolic to anabolic metabolic switch and increased food intake, energy
expenditure, resting energy expenditure and physical activity. The data
highlight the potential of AV-380 as a therapeutic intervention for the
treatment for CACS.

“Cachexia is a prevalent, devastating consequence of multiple chronic
disease states. The poor understanding of its molecular mechanisms has
led to a therapeutic focus on specific symptoms with limited treatment
effectiveness,” said Michael Needle, MD, chief medical officer of AVEO.
“Our preclinical data show that inhibition of GDF15 results in a switch
from catabolism to anabolism, suggesting that treatment with AV-380 may
reverse the effects of cachexia. We remain encouraged by the potential
of this therapeutic approach and continue to actively pursue
partnerships to realize the full potential of AV-380 within and beyond
cancer cachexia.”

AV-380 is a potential first-in-class GDF15 inhibitor, discovered using
AVEO’s proprietary Human Response Platform™, which provides the Company
unique insights into cancer and related disease biology. AVEO plans to
evaluate opportunities for partnerships to expand the development of
AV-380, including in cachexia associated with non-cancer indications,
such as chronic heart failure, chronic kidney disease and chronic
obstructive pulmonary disease, with the goal of leveraging the full
potential of this asset.

About Cachexia

Cachexia is a serious and common complication in patients with advanced
cancer and other chronic diseases, characterized by symptoms of
unintentional weight loss, progressive muscle wasting and loss of
appetite (anorexia). Cachexia affects some five million individuals in
the United States¹. It is estimated that 60-80% of patients with
advanced cancer have cachexia2,3 and approximately 30% of
cancer patients die due to cachexia4.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company committed to
developing targeted therapies through biomarker-driven insights to
provide improvements in patient outcomes where significant unmet medical
needs exist. AVEO’s proprietary Human Response Platform™ has delivered
unique insights into cancer and related disease biology that AVEO is
seeking to leverage in the clinical development strategy of its
therapeutic candidates. For more information, please visit the company’s
website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within
the meaning of The Private Securities Litigation Reform Act of 1995 that
involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,”
“objective,” “could,” “should,” “seek,” or the negative of these terms
or other similar expressions, are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. These forward-looking statements include, among
others, statements about: the role GDF15 may play in the development and
progression of cancer cachexia; GDF15 as an important mechanism to
target for therapeutic intervention; AV-380 as a potential therapeutic
intervention for the treatment of CACS; and AVEO’s plans to pursue
partnerships to realize the full potential of AV-380. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that AVEO makes
due to a number of important factors, including risks relating to:
AVEO’s ability to successfully implement its restructuring and strategic
plans, including its plans to pursue partnerships for AV-380; AVEO’s
ability to successfully enroll and complete clinical trials of its
product candidates; AVEO’s ability to demonstrate to the satisfaction of
the FDA, EMA or other equivalent foreign regulatory agencies, the
safety, efficacy and clinically meaningful benefit of its product
candidates; AVEO’s ability to achieve and maintain compliance with all
regulatory requirements applicable to its product candidates; AVEO’s
ability to obtain and maintain adequate protection for intellectual
property rights relating to its product candidates and technologies;
developments and expenses related to AVEO’s ongoing shareholder
litigation and SEC inquiry; AVEO’s ability to raise the substantial
additional funds required to achieve its goals; unplanned capital
requirements; adverse general economic and industry conditions;
competitive factors; and those risks discussed in the section titled
“Risk Factors” included in AVEO’s most recent Annual Report on Form
10-K, its quarterly reports on Form 10-Q and in its other filings with
the SEC. The forward-looking statements in this press release represent
AVEO’s views as of the date of this press release. AVEO anticipates that
subsequent events and developments will cause its views to change.
However, while AVEO may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any obligation to
do so. You should, therefore, not rely on these forward-looking
statements as representing AVEO’s views as of any date subsequent to the
date of this press release.